Wireless Spinal Cord Stimulation for Chronic Pain

Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain

The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Device: Freedom SCS System

Detailed Description

This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.

Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.

Stimulators will be placed at the following sites to target the painful area:

• Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Nuvo Spine and Sports Institute & Ortho Regenerative Center
    • Los Angeles, California, United States, 90033
      • USC Spine Center, Keck Hospital of USC
  • Florida
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Tamarac, Florida, United States, 33301
      • Anesthesia Pain Care Consultants
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Tyler, Texas, United States, 75701
      • Precision Spine Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is ≥ 18 years of age at time of informed consent;
• Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
• Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
• Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
• Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
• Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
• Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
• Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
• Subject is male or non-pregnant female;
• Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
• Subject is capable of giving informed consent;
• Subject lives within reasonable distance from the study site (circumference of 50 miles).

Exclusion Criteria:

• Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
• Unresolved Malignancies in last six months;
• Subject has post-herpetic neuralgia (shingles);
• Subject has an active systemic infection or is immune-compromised;
• Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
• Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
• Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
• Bleeding complications or coagulopathy issues;
• Pregnant/lactating or not using adequate birth control;
• A life expectancy of less than one year;
• Any active implanted device whether turned off or on;
• A previous SCS experience;
• Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Freedom SCS System - 1500 HZ; Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area.	Device: Freedom SCS System; This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	A 50% reduction in VAS scores when compared to baseline.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in VAS Back from baseline	The percentage reduction in VAS back pain	6 Months
Percentage change in VAS Leg from baseline	The percentage reduction in VAS leg pain	6 Months
Oswestry Disability Index (ODI) Score	The change from baseline in functionality using the ODI	6 Months
Patient Satisfaction	The change in satisfaction as measured by Patient Global Impression of Change	6 Months
Disability Score	The change in European Quality of Life 5 Dimension	6 Months
Sleep Quality	Frequency of sleep disturbances reported from diary	6 Months
Procedure time	The time measured to implant the device from operative notes	7 Days post implant
Opioid Reduction	The reduction in opioids as reported by patient prescription	6 Months
Adverse Events	The incidence of device related adverse events	6 Months

Collaborators and Investigators

• Sponsor: Stimwave Technologies
• Collaborators: The Cleveland Clinic; The Center for Clinical Research, Winston-Salem, NC; Anesthesia Pain Care Consultants, Tamarac, FL, USA; Precision Spine Care, Tyler, TX, USA; Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA; Compass Research LLC, Orlando, FL, USA; USC Spine, Keck hospital of USC, Los Angeles, CA, USA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 30-00113